NCT00054600

Brief Summary

The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the prevention of Graft-versus-Host Disease (GvHD).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2002

Geographic Reach
9 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

First QC Date

February 5, 2003

Last Update Submit

August 14, 2017

Conditions

Graft-versus-Host Disease

Keywords

Extracorporeal PhotopheresisGraft-versus-Host Disease

Interventions

MethoxsalenDRUG
Extracorporeal PhotopheresisPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a diagnosis of a malignancy of the blood (e.g. leukemia) for which allogeneic bone marrow or peripheral blood stem cell transplantation is a treatment option.
  • Patients who are candidates for a standard allogenic bone marrow transplant or PBSC transplant.
  • Patients must have adequate renal, hepatic, pulmonary and cardiac function to enable the patient to tolerate shifts in the volumes of body fluids associated with extracorporeal photopheresis, as determined by the physician's clinical judgement.
  • Patients must weigh at least 40 kg (88 lbs)

You may not qualify if:

  • Patients who have received a prior bone marrow transplant or peripheral blood stem cell transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Tufts New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Kansas City Cancer Center

Kansas City, Missouri, 64111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Texas Transplant

San Antonio, Texas, 78229, United States

Location

Royal Brisbane Hospital

Brisbane, 4006, Australia

Location

Peter MacCallum Cancer Institute

East Melbourne, 8006, Australia

Location

Alfred Hospital

Melbourne, Australia

Location

Royal Melbourne Hospital

Parkville, 3050, Australia

Location

St. Vincent's Hospital

Sydney, 2010, Australia

Location

Hospital Azevedo Carvalho

Jaú, Brazil

Location

National Cancer Institute

Rio de Janeiro, Brazil

Location

Hemocentro

São Paulo, Brazil

Location

Ludwig-Maximiliano Universitaet Muenchen

München, D-81377, Germany

Location

Careggi Hospital

Florence, 1-50134, Italy

Location

San Martino Hospital

Genova, 16132, Italy

Location

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, 1099-023, Portugal

Location

National Cancer Institute

Bratislava, Slovakia

Location

Ankara University Medical School

Ankara, 6100, Turkey (Türkiye)

Location

Hammersmith Hospital

London, W12 0NN, United Kingdom

Location

Related Publications (1)

  • Shlomchik WD, Couzens MS, Tang CB, McNiff J, Robert ME, Liu J, Shlomchik MJ, Emerson SG. Prevention of graft versus host disease by inactivation of host antigen-presenting cells. Science. 1999 Jul 16;285(5426):412-5. doi: 10.1126/science.285.5426.412.

    PMID: 10411505BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

MethoxsalenPhotopheresis

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

FurocoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingPUVA TherapyUltraviolet TherapyPhototherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

June 1, 2002

Study Completion

June 1, 2004

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

AU(5)DE(1)SL(1)IT(2)US(6)GB(1)PT(1)TU(1)BR(3)